IPure B1PC (clear), +23.00DRecalls & reported problems
Hoya Medical Singapore Pte. Ltd. · Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use. · Class 3 · Implant
All models of IPure (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886158017264), received between Jun 7, 2022 and Sep 10, 2024 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Sharp Edges2
- Failure to Eject1
Patient problems
- Failure of Implant3
- Capsular Bag Tear2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2024Sharp Edges; Sharp Edges
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. LEADING; ROOT. WHEN HE WENT TO SPIN THE LENS INTO PLACE IT APPEARED THE HAPTICS TORE THE CAPSULE. BROKEN HAPTIC DURING USE. CAPSULAR BAG TEAR / RUPTURE. PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT. HE LEFT LENS IMPLANTED; PATIENT HEALTH NOT IMPACTED. PATIENT HAS RECOVERED AND IS FINE; LENS DEPLOYED AS NORMAL. TORIC IOL MISALIGNMENT OR ROTATION. PROBLEM CODE: A051102 - SHARP EDGES
Patient problems: Capsular Bag Tear
MAUDE report 20185598 ↗InjuryFeb 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. PROBLEM CODE: A0414, MATERIAL SPLIT CUT OR TORN. TRAILING; LENS WAS IMPLANTED AND THEN HAD TO BE EXPLANTED DUE TO BROKEN TRAIL HAPTIC PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE; NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED. EXPLANTATION DATE: (B)(6) 2023.
Patient problems: Failure of Implant
MAUDE report 18724493 ↗InjuryJun 7, 2023Failure to Eject; Failure to Eject
PROBLEM CODE: FAILURE TO EJECT. CLOGGING OF THE IOL IN THE INJECTOR TIP DURING DELIVERY. IMPLANT DATE: (B)(6) 2023; EXPLANT DATE: (B)(6) 2023 REPORTED.
Patient problems: Failure of Implant
MAUDE report 17080647 ↗InjuryFeb 21, 2023Sharp Edges; Sharp Edges
DR. INSERTED THE LENS INTO THE BAG AND THE BAG TORE. THE DOCTOR FEELS THAT THE LENS HAD SHARP EDGE THAT CAUSED THE BAG TO RIP. LENS WAS EXPLANTED. PATIENT HEALTH WAS NOT IMPACTED.
Patient problems: Capsular Bag Tear; Failure of Implant
MAUDE report 16410681 ↗MalfunctionJun 7, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
DAMAGED HAPTIC AFTER IMPLANTATION. WHILE DOCTOR WAS IMPLANTING THE LENS, HE NOTICED A TEAR AT THE LEADING HAPTIC OPTIC JUNCTION. THE TEAR DID NOT EFFECT THE PATIENT IN THIS SURGERY. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14621694 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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